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Context Therapeutics Acquires Phase 1-ready T cell Engager CT-95

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Rhea-AI Summary

Context Therapeutics, a biopharmaceutical company specializing in solid tumor treatments, has acquired CT-95, a potentially first-in-class mesothelin x CD3 bispecific antibody from Link Immunotherapeutics. This acquisition, announced on July 10, 2024, aligns with Context’s strategy to expand its pipeline of T cell engager assets. CT-95 has already received Investigational New Drug (IND) clearance from the U.S. FDA and is expected to begin Phase 1 trials in Q1 2025. The antibody targets mesothelin, prevalent in cancers like ovarian, lung, and pancreatic. Context plans to use its existing cash reserves to fund the acquisition and initial clinical trials.

Positive
  • Acquisition of CT-95 adds a second clinical-stage T cell engager to Context's pipeline.
  • CT-95 has received IND clearance from the FDA, enabling swift progression to Phase 1 trials.
  • The asset targets mesothelin, highly prevalent in underserved solid cancers, offering a potentially significant market opportunity.
  • Context plans to fund the acquisition and initial trial phases with existing cash, implying no immediate need for additional financing.
Negative
  • The early-stage nature of CT-95 presents inherent clinical and regulatory risks.
  • Funding initial trials with existing cash reserves may strain the company's liquidity.

The acquisition of CT-95, a mesothelin x CD3 bispecific antibody, by Context Therapeutics is noteworthy. Mesothelin is a protein highly expressed in several solid tumors like ovarian, lung and pancreatic cancers. The concept behind bispecific antibodies is to engage T cells (a type of immune cell) to target and kill cancer cells specifically. This has the potential to improve cancer treatment efficacy while minimizing damage to healthy tissue.

Given the IND clearance for CT-95, the FDA has determined that the preclinical data supports moving the drug into human trials. This is a significant hurdle and speaks to the credibility of the preclinical data. The plan to initiate Phase 1 trials by Q1 2025 suggests a foresighted strategy aimed at rapid clinical development.

From a medical research perspective, the acquisition aligns with the growing interest in T cell engagers (TCEs) for solid tumors. These are cutting-edge therapies in oncology and their potential for targeting underserved cancers could make a substantial impact. However, it’s important to note that the clinical trial phases are lengthy and uncertain. The promise shown in preclinical stages doesn’t always translate to clinical success. Investors should be cognizant of the high-risk, high-reward nature of this acquisition.

Context Therapeutics’ acquisition of CT-95 represents an ambitious but calculated financial move. The fact that the company intends to use existing cash reserves for the acquisition and initial trial phase is a positive indicator of financial prudence. This avoids additional debt or dilutive equity raises, which can often negatively impact shareholder value.

The potential first-in-class status of CT-95 could position Context as a key player if clinical trials prove successful. This can lead to competitive positioning and potentially lucrative partnerships or licensing deals down the line. However, investors should weigh this against the inherent risks of investing in early-stage biotechnologies. Failure in clinical trials could mean substantial financial losses.

Short-term, the cash outflow might put some stress on the company’s finances, but the long-term prospects could be rewarding if the drug reaches the market. The oncology drug market is notably lucrative and a successful new therapy can generate significant revenue streams. Investors should monitor upcoming quarterly reports for updates on cash burn rates and trial progress.

In terms of market dynamics, Context Therapeutics’ acquisition of CT-95 adds another solid tumor-focused TCE to its pipeline, diversifying its portfolio. The selection of mesothelin as a target is strategic, as it’s a high-prevalence marker in several challenging cancers. This increases the potential market reach and addresses a significant unmet need in oncology.

The timing for Phase 1 trials aimed for early 2025 suggests that the company is positioning itself to capture market share in the growing TCE segment of the oncology market. There's an observable trend where biopharmaceutical companies are increasingly focusing on immuno-oncology therapies, driven by their potential for high efficacy and specificity.

Furthermore, Context’s ability to successfully bring CT-95 to market could enhance its reputation as a pioneer in TCEs for solid tumors. This could attract further investment and partnerships, bolstering its market position. However, competition in this space is fierce and Context will need to demonstrate clear clinical benefits to differentiate CT-95 from other therapies in development.

CT-95 is a potentially first-in-class mesothelin x CD3 bispecific antibody

Acquisition expands Context pipeline with second clinical-stage T cell engager for solid tumors

PHILADELPHIA, July 10, 2024 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing medicines for solid tumors, today announced that it has entered into an asset purchase agreement under which the Company has acquired CT-95, formerly owned by Link Immunotherapeutics, Inc. (“Link”), a mesothelin (“MSLN”) x CD3 T cell engaging (“TCE”) bispecific antibody with first-in-class potential that has received Investigational New Drug (“IND”) clearance from the U.S. Food and Drug Administration. CT-95 is on track for Phase 1 initiation in the first quarter of 2025.

“We are thrilled to add CT-95, formerly known as LNK101, to our pipeline. The successful acquisition of this MSLN x CD3 bispecific antibody is consistent with our focus on building a pipeline of TCE assets to treat solid tumors,” said Martin Lehr, CEO of Context. “Context identified MSLN as a target of interest due to its high prevalence in underserved solid cancers, including ovarian, lung, and pancreatic. Based on the compelling preclinical data generated to date, we believe that CT-95 has the potential to be both a first-in-class and best-in-class MSLN-targeting TCE.”

Mr. Lehr continued, “CT-95 is an IND-cleared asset that we plan to rapidly progress into clinical trials. We intend to fund the acquisition of CT-95 and its advancement through the dose escalation portion of a Phase 1 clinical trial with Context’s existing cash.”

About CT-95
MSLN is a membrane protein overexpressed by many cancers with limited expression in normal tissues. One challenge in developing MSLN-targeted therapies has been the presence of a shed MSLN sink found in both blood and the tumor microenvironment. CT-95 is a fully humanized bispecific TCE that employs an IgG-scFv architecture with an effector-silenced IgG1 backbone and has a relatively low affinity but high avidity for membrane-bound MSLN, minimizing the impact of the shed sink. CT-95 is being developed as a therapy for advanced cancers associated with MSLN expression.

About Context Therapeutics®
Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing medicines for solid tumors. The Company is building an innovative portfolio of clinical-stage T cell engaging bispecific therapeutics, including CTIM-76, a selective Claudin 6 (CLDN6) x CD3 bispecific antibody, and CT-95, a potential first-in-class mesothelin x CD3 bispecific antibody. Context is headquartered in Philadelphia. For more information, please visit www.contexttherapeutics.com or follow the Company on X (formerly Twitter) and LinkedIn.

Forward-looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “look forward,” “plan,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) our expectation to rapidly progress CT-95 into clinical trials, including Phase 1 initiation in the first quarter of 2025, (ii) our expectation to fund the acquisition of CT-95 and its advancement through the dose escalation portion of a Phase 1 clinical trial with our existing cash, (iii) the potential benefits, characteristics, safety and side effect profile of CT-95, (iv) the ability of CT-95 to have benefits, characteristics, manufacturability, and a side effect profile that is differentiated and/or better than third party product candidates, (v) the likelihood data will support future development of CT-95, and (vi) the likelihood of obtaining regulatory approval for CT-95. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we therefore cannot assure you that our plans, intentions, expectations, or strategies will be attained or achieved. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise.

Media Contact:
Gina Mangiaracina
6 Degrees
917-797-7904
gmangiaracina@6degreespr.com

Investor Relations Contact:
Jennifer Minai-Azary
Context Therapeutics
IR@contexttherapeutics.com


FAQ

What is CT-95?

CT-95 is a mesothelin x CD3 bispecific antibody with first-in-class potential acquired by Context Therapeutics.

When did Context Therapeutics announce the acquisition of CT-95?

The acquisition was announced on July 10, 2024.

What stage is CT-95 in?

CT-95 is Phase 1-ready and has received IND clearance from the FDA.

When will Phase 1 trials for CT-95 begin?

Phase 1 trials for CT-95 are expected to begin in the first quarter of 2025.

How will Context Therapeutics fund the acquisition of CT-95?

Context Therapeutics plans to fund the acquisition and its initial trials using its existing cash reserves.

What types of cancers does CT-95 target?

CT-95 targets solid tumors with a high prevalence of mesothelin, such as ovarian, lung, and pancreatic cancers.

What is the stock symbol for Context Therapeutics?

The stock symbol for Context Therapeutics is CNTX.

Context Therapeutics Inc.

NASDAQ:CNTX

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Pharmaceutical Preparation Manufacturing
Manufacturing
Link
United States of America
PHILADELPHIA